[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Proposed Rules]
[Pages 21207-21211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8903]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Service
42 CFR Part 416
[CMS-3217-P]
RIN 0938-AP93
Medicare Program; Ambulatory Surgical Centers, Conditions for
Coverage
AGENCY: Centers for Medicare & Medicaid Services (CMS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise one of the existing conditions
for coverage (CfC) that ambulatory surgical centers (ASCs) must meet in
order to participate in the Medicare program. The proposed revision
would modify the current CfC for patient rights to include an exception
that would allow an ASC to provide patients or the patients'
representative or surrogate with required patient rights information on
the day of the procedure when the procedure must, to safeguard the
health of the patient, be performed on the same day as the physician's
referral. In addition, we are proposing some other minor changes to the
CfC for patient right requirements.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. EST on June 22,
2010.
ADDRESSES: In commenting, please refer to file code CMS-3217-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
[[Page 21208]]
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3217-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3217-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Joan A. Moliki, (410) 786-5526,
Jacqueline Morgan, (410) 786-4282, Steve Miller, (410) 786-6656, or
Jeannie Miller, (410) 786-3164.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
A. Legislative and Regulatory Authority for the Ambulatory Surgical
Centers, Conditions for Coverage
As the single largest payer for health care services in the United
States, the Centers for Medicare & Medicaid Services (CMS) has a
critical role in promoting high quality care for Medicare
beneficiaries. CMS is responsible for ensuring that the conditions for
coverage (CfCs) of Ambulatory Surgical Center (ASC) services, and
enforcement of those conditions, are adequate to protect the health and
safety of the individuals treated in such ASCs. Any regulatory changes
that we contemplate must consider patient health and safety along with
the administrative burden placed on Medicare-participating facilities.
Section 1832(a)(2)(F)(i) of the Social Security Act (the Act)
specifies that an ASC must meet health, safety, and other requirements
specified by the Secretary of Health and Human Services (HHS) (the
Secretary) in regulation if it has an agreement in effect with the
Secretary to perform procedures covered by Medicare. Under the
agreement, the ASC agrees to accept the standard Medicare amount
determined under section 1833(i)(2) of the Act as full payment for
services, and to accept assignment of benefits as described in section
1842(b)(3)(B)(ii) of the Act for payment for all services furnished by
the ASC to enrolled individuals. Substantive requirements are set forth
in 42 CFR part 416 subpart B and subpart C of our regulations. The
regulations at 42 CFR part 416 subpart B describe the general
conditions and requirements for ASCs, and the regulations at 42 CFR
part 416 subpart C describe the specific CfCs for ASCs.
B. Updates and Revisions to the Ambulatory Surgical Centers Conditions
for Coverage
On August 31, 2007, we published a proposed rule (72 FR 50470) in
the Federal Register entitled, ``Medicare and Medicaid Programs;
Ambulatory Surgical Centers, Conditions for Coverage,'' in which we
proposed to update the ASC CfCs by revising some of the definitions and
the CfCs regarding governing body and management, and laboratory and
radiologic services, to reflect current ASC practices. In addition, we
proposed to add several new CfCs regarding quality assessment and
performance improvement; patient rights; infection control; and patient
admission, assessment and discharge. We proposed these CfCs in order to
promote and protect patient health and safety.
In the proposed rule at Sec. 416.50, we proposed to divide the
patient rights CfC into four standards. Under the first standard, Sec.
416.50(a)(1), ``Notice of rights,'' we proposed that ASCs be required
to provide the patient or the patient's representative with verbal and
written notice of the patient's rights in a language and manner the
patient understood in advance of providing care to the patient. In
addition, we set out what information would be required and where the
ASC would have to post the information for the patient to see while
waiting for treatment.
On November 18, 2008, we published a final rule (73 FR 68502),
entitled ``Medicare Program; Changes to the Hospital Outpatient
Prospective Payment System and CY 2009 Payment Rates''. The final rule,
among other changes, finalized the new CfC for patient rights in ASCs.
In response to the proposed patient rights provision, several
commenters expressed concern about the amount of paperwork patients
would be required to complete on the day of the procedure and stated
that patients would benefit from reviewing pertinent information before
they arrived at the ASC for the procedure (see 73 FR 68718). Therefore,
in response to comments, we revised our proposed requirement for
patient rights at Sec. 416.50(a)(1), (a)(1)(ii) and (a)(2)(i), to
specify that ambulatory surgical centers (ASCs) provide patient rights
information to patients or the patient's representative in advance of
the date of the procedure.
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When we published the final rule for the ASC CfCs on November 18,
2008, we specified at Sec. 416.50(a)(1) that patient rights
information was to be provided by the ASC in advance of the date of the
procedure. It was, and continues to be, our intent to require that ASCs
provide patients or the patient's representative or surrogate with
information we believe they need in order to make an informed choice
about the facility where their procedure will be performed. Likewise,
we continue to believe that this information should be imparted in
advance of the date of the procedure.
The patient's representative or surrogate, who could be a family
member or friend that accompanies the patient, may act as a liaison
between the patient and the ASC to help the patient communicate,
understand, remember, and cope with the interactions that take place
during the visit, and explain any instructions to the patient that are
delivered by the ASC staff. If a patient is unable to fully communicate
directly with the ASC staff, then the ASC may give patient rights
information to the patient's representative or surrogate. The patient
has the choice of using an interpreter of his or her own, or one
supplied by the ASC. A professional interpreter is not considered to be
a patient's representative or surrogate. Rather, it is the professional
interpreter's role to pass information from the ASC to the patient. In
following translation practices, we recommend, but do not propose
requiring, that a written translation be provided in languages that
non-English speaking clients can read, particularly for languages that
are most commonly used by non-English-speaking clients of the ASC. We
note that there are many hundreds of languages (not all written) that
are used by one or more residents of the United State, but that in most
geographic areas the most common non-English language, by far, is
Spanish.
While we propose this standard under the authority of title 18,
section 1832(a)(2)(F)(i), there are other legal requirements, most
notably, those under title VI of the Civil Rights Act of 1964. Our
proposed requirement has been designed to be compatible with recent
guidance on title VI. The Department of Health and Human Services'
(HHS) guidance related to Title VI of the Civil Rights Act of 1964,
``Guidance to Federal Financial Assistance Recipients Regarding Title
VI Prohibition Against National Origin Discrimination Affecting Limited
English Proficient Persons'' (August 8, 2003, 68 FR 47311) applies to
those entities that receive federal financial assistance from HHS,
including ASCs. This guidance may assist ASCs in ensuring that patient
rights information is provided in a language and manner the Medicare
patient understands.
In the November 18, 2008, ASC regulation, we also specified at
Sec. 416.50(a)(1)(ii) (physician financial interest or ownership), and
Sec. 416.50(a)(2)(i) (Advance directives) that ASCs are also required
to provide this information to patients in advance of the date of the
procedure. We believe that the current organization of Sec. 416.50 is
confusing relative to the need for ASCs to furnish information to
patients prior to the date of the procedure. Therefore, we are
proposing to revise this section.
II. Provisions of the Proposed Regulation
As stated above, the November 18, 2008 final rule finalized the
patient's right provision at Sec. 416.50, to require ASCs to provide
specific patients' rights information to patients in advance of the
date of the procedure. We believed this modification would alleviate
provider concerns while at the same time afford patients sufficient
time to review pertinent information before undergoing a procedure.
However, since the publication of the final rule, it has come to our
attention that a few ASCs sometimes provide same-day procedures on an
emergency basis. Therefore, the current patient rights CfC requirement
has been problematic for those ASCs that perform procedures on the same
day they receive physician referrals (for example, a patient is
referred to an ASC due to severe eye trauma).
ASCs contemplating providing services to a patient on the same day
he or she receives a referral must either refuse serving the patient
for fear of violating Medicare requirements or accept the patient for
service and be out of compliance with Medicare patient rights
requirements. ASCs that serve same-day patients would like to continue
to serve this constituency; however, potential non-compliance with the
current Medicare requirement is a deterrent.
This rule proposes to establish an exception when an ASC is
providing services to a patient on the same day he or she receives a
physician referral for the ASC service(s) and when a delay in providing
the service(s) would adversely affect the patient's health. In general,
the ASC would continue to be required to provide information as
specified at Sec. 416.50. However, the proposed exception would apply
only if: (1) The written referral was signed and dated by the physician
on the date the patient was presented at the ASC for the service(s);
and (2) a physician in the ASC or the referring physician communicates
in writing and the ASC documents in the medical record that the
procedure must be performed as soon as possible to safeguard the health
of the patient. This proposed exception attempts to balance our
responsibility to promote the health and safety of ASC patients with
undue burden on facilities.
In addition to modifying Sec. 416.50 to provide for an exception
for same-day procedures, we are proposing minor revisions to this
section. Currently Sec. 416.50(a)(1) and (a)(2) require disclosure of
information to be made in advance of the date of the procedure. We are
proposing to eliminate this specific requirement from these sections
and add this requirement to the stem statement at Sec. 416.50 since
the stem statement applies to all of the proposed requirements at Sec.
416.50.
The current provisions at Sec. 416.50(a), (b), and (c) require
that an ASC provide verbal and written notice of patient rights to the
patient or the patient's representative. This encompasses the posting
of rights, disclosure of physician financial interest or ownership, the
provision of advance directives, the submission and investigation of
grievances, the exercise of rights, privacy and safety, and the
confidentiality of clinical records. We are proposing to reorganize
Sec. 416.50(a), (b), and (c) by creating separate standards for
provisions that are currently required in these paragraphs.
Specifically, we are proposing to retitle and reorganize the
requirements of Sec. 416.50, ``Patient rights,'' as follows: (a)
Standard: Notice of rights; (b) Standard: Disclosure of physician
financial interest or ownership; (c) Standard: Advance directives; (d)
Standard: Submission and investigation of grievances; (e) Standard:
Exercise of rights and respect for property and person; (f) Standard:
Privacy and safety; (g) Standard: Confidentiality of medical records;
and (h) Standard: Exception to the timing of the notice of patient
rights. We believe this reorganization would eliminate confusion about
the patient rights information to be provided to patients. We note that
these are not new requirements.
In addition, as stated above, we are proposing to add a new
exception to Sec. 416.50 (proposed Standard (h)) that would allow an
ASC in the case of an emergency procedure, and when it was not feasible
to provide notice of patient rights information in advance of the date
of the procedure, to provide this information to the patient or the
[[Page 21210]]
patient's representative or surrogate on the day of treatment before
the procedure.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comments on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Proposed Sec. 416.50 (h)(1) and (h)(2) would require an ASC
facility to furnish information as specified when an ASC accepts a
patient for a procedure that must be performed on the same day as a
physician referral. Specifically, proposed Sec. 416.50(h)(2) states
that a physician in the ASC or the referring physician must communicate
in writing and the ASC must document in the medical record that the
procedure be performed as soon as possible to safeguard the health of
the patient. The burden associated with this requirement is the time
and effort necessary for an ASC physician or a referring physician to
make the aforementioned written communication and documentation.
We believe the burden associated with this requirement in proposed
Sec. 416.50 constitutes a usual and customary business practice as
defined in 5 CFR 1320.3(b)(2). The medical record requirement at Sec.
416.47, which remains unchanged, also specifies that ASCs must maintain
complete, comprehensive and accurate medical records to ensure adequate
patient care. A physician referral letter is considered part of the
patient's medical history and is always part of the medical record.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
CMS-3217-P, Fax: (202) 395-6974; or E-mail: [email protected].
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Statement
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.
804(2)).
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This rule
does not reach the economic threshold and thus is not considered a
major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$7.0 million to $34.5 million in any 1 year. Individuals and States are
not included in the definition of a small entity. We estimate there are
approximately 5,100 Medicare Participating ASCs with average admissions
of approximately 1,240 patients per ASC (based on the number of
patients seen in ASCs in 2008). Most ASCs are considered to be small
entities, either by nonprofit status or by having revenues of $7
million to $34.5 million in any 1 year. For purposes of burden
estimates, we are unable to accurately determine the exact number of
ASCs that provide services to patients on the same day as referral by
their physicians. However, one national ASC chain informed us in
September 2009 that approximately 3 percent of its ASCs provide
services to patients on the same day as referral by their physicians.
Using this percentage, we estimate that 153 ASCs overall perform these
same day services. Due to this small percentage, we have determined
that the ASC industry on average will experience a slightly reduced
burden associated with mailing out patient rights informational packets
to patients prior to providing the service(s). Instead, a small
percentage of patients would be informed in person on the day of the
procedure. Thus, we believe this exception rule should have little or
no effect on the benefit cost of ASC services.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA.
However, this proposed rule only affects ambulatory surgical centers
and not hospitals. As a result, we are not preparing an analysis for
section 1102(b) of the Act because we believe and the Secretary has
determined that this rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year by
State, local or tribal governments, in the aggregate, or by the private
sector of $100 million in 1995 dollars, updated annually for inflation.
In 2010, that threshold level is approximately $135 million. This
proposed rule is not expected to reach this spending threshold.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This proposed rule has no Federalism implications and
does not impose any costs on State or local governments. Therefore, the
requirements of
[[Page 21211]]
Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 416
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR part 416 as set forth
below:
PART 416--AMBULATORY SURGICAL SERVICES
1. The authority citation for part 416 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Specific Conditions for Coverage
2. Section 416.50 is revised to read as follows:
Sec. 416.50 Condition for coverage--Patient rights.
The ASC must inform the patient or the patient's representative or
surrogate of the patient's rights and must protect and promote the
exercise of these rights, as set forth in this section. The ASC must
also post the written notice of patient rights in a place or places
within the ASC likely to be noticed by patients waiting for treatment
or by the patient's representative or surrogate, if applicable.
(a) Standard: Notice of rights. Except as set forth in paragraph
(h) of this section, an ASC must, in advance of the date of the
procedure, provide the patient or the patient's representative or
surrogate with verbal and written notice of the patient's rights in a
language and manner that ensures the patient or the patient's
representative or surrogate understands all of the patient's rights as
set forth in this section. The ASC's notice of rights must include the
address and telephone number of the State agency to whom patients may
report complaints as well as the Web site for the Office of the
Medicare Beneficiary Ombudsman.
(b) Standard: Disclosure of physician financial interest or
ownership. The ASC must disclose, in accordance with Part 420 of this
subchapter, and where applicable, provide a list of physicians who have
financial interest or ownership in the ASC facility. Disclosure of
information must be in writing.
(c) Standard: Advance directives. The ASC must comply with the
following requirements:
(1) Provide the patient or, as appropriate, the patient's
representative or surrogate with written information concerning its
policies on advance directives, including a description of applicable
State health and safety laws and, if requested, official State advance
directive forms.
(2) Inform the patient or, as appropriate, the patient's
representative or surrogate of the patient's right to make informed
decisions regarding the patient's care.
(3) Document in a prominent part of the patient's current medical
record, whether or not the individual has executed an advance
directive.
(d) Standard: Submission and investigation of grievances. The ASC
must establish a grievance procedure for documenting the existence,
submission, investigation, and disposition of a patient's written or
verbal grievance to the ASC. The following criteria must be met:
(1) All alleged violations/grievances relating, but not limited to,
mistreatment, neglect, verbal, mental, sexual, or physical abuse, must
be fully documented.
(2) Allegations of neglect, mistreatment, sexual or physical abuse
must be immediately reported to a person in authority in the ASC.
(3) Only substantiated allegations of neglect, mistreatment, sexual
or physical abuse must be reported to the applicable State authority or
the local authority, or both.
(4) The grievance process must specify timeframes for review of the
grievance and the provisions of a response.
(5) The ASC, in responding to the grievance, must investigate all
grievances made by a patient or the patient's representative or
surrogate regarding treatment or care that is (or fails to be)
furnished.
(6) The ASC must document how the grievance was addressed, as well
as provide the patient with written notice of its decision. The
decision must contain the name of an ASC contact person, the steps
taken to investigate the grievance, the result of the grievance
process, and the date the grievance process was completed.
(e) Standard: Exercise of rights and respect for property and
person.
(1) The patient has the right to
(i) Be free from any act of discrimination or reprisal.
(ii) Voice grievances regarding treatment or care that is (or fails
to be) provided.
(iii) Be fully informed about a treatment or procedure and the
expected outcome before it is performed.
(2) If a patient is adjudged incompetent under applicable State
health and safety laws by a court of proper jurisdiction, the rights of
the patient are exercised by the person appointed under State law to
act on the patient's behalf.
(3) If a State court has not adjudged a patient incompetent, any
legal representative or surrogate designated by the patient in
accordance with State law may exercise the patient's rights to the
extent allowed by State law.
(f) Standard: Privacy and safety. The patient has the right to the
following:
(1) Personal privacy.
(2) Receive care in a safe setting.
(3) Be free from all forms of abuse or harassment.
(g) Standard: Confidentiality of medical records. The ASC must
comply with the Department's rules for the privacy and security of
individually identifiable health information, as specified at 45 CFR
parts 160 and 164.
(h) Standard: Exception to the timing of the notice of patient
rights. In the case of an emergency procedure, when it is not feasible
to inform the patient or the patient's representative or surrogate of
the patient's rights in advance of the date of the procedure, the ASC
may provide the required notice and disclosures to the patient or the
patient's representative or surrogate immediately before the procedure
only if the following conditions are met:
(1) The signed physician referral is in writing, is dated the day
the patient presents at the ASC, and is placed in the patient's medical
record prior to the procedure.
(2) A physician in the ASC or the referring physician communicates
in writing and the ASC documents in the medical record that the
procedure must be performed as soon as possible to safeguard the health
of the patient.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: January 21, 2010.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: April 5, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-8903 Filed 4-22-10; 8:45 am]
BILLING CODE 4120-01-P